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Zika Virus Infection's Neonatal and Pediatric Consequences in French Department of America

NCT02810210 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1180

Last updated 2024-12-09

No results posted yet for this study

Summary

The Zika epidemic has spread into the three French Overseas Departments in the Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due to having ZIKV infection during pregnancy.

This study is meant to collect, within usual care practices, clinical and paraclinical information (including imaging and laboratory results) as well as biological samples allowing the precise description of the consequences of ZIKV infection during pregnancy.

This study is the 2nd arm of a global research program in the 3 French Overseas Departments in the Caribbean. It is complementary to the first arm (ZIKA-DFA-FE) consisting in the follow-up of women in the French Overseas Departments who are pregnant during the Zika epidemic period.

The study population is made up of infants born during and up to 9 months after the end of the Zika epidemic period in the French Overseas Departments.

The data and biological specimens collected for this project will be done so through the recommended standard of care which has been put in place considering the ZIKV epidemic in the 3 French Overseas Departments, upholding existing recommendations (profession and/or recommendation from the public health authorities)

Conditions

  • Zika Virus Infection on Fetus and Child During the Pregnancy

Interventions

OTHER

fundus examination

In cohort 3, a fundus examination will be carried in addition to the current medical practice. This exam is part of current medical practice for other groups.

OTHER

Head ultrasound

In cohort 3, a head ultrasound will be carried in addition to the current medical practice. This exam is part of current medical practice for other groups.

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Principal Investigators

  • Bruno Hoen · Institut National de la Santé Et de la Recherche Médicale, France

  • Olivier Flechelles · CHU de la Martinique

Eligibility

Min Age
0 Days
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02810210 on ClinicalTrials.gov